DuraLac® H Anhydrous Lactose - MEGGLE
DuraLac® H is an anhydrous lactose excipient developed for direct compression and dry granulation. It combines excellent compactibility with low water content and high storage stability.
Offers DURALAC H as a clearly identified product listing for B2B sourcing.- Designed for low- to medium-dose direct-compression formulations.
- Brittle fracture during compaction supports strong, robust tablets.
- Suitable for dry granulation, capsule filling and sachets.
- Low water content supports moisture-sensitive formulations.
- Native powder flow is moderate and can be improved with a lubricant or glidant.
- Available in 25 kg packaging with a 36-month shelf life.
AI Summary: Presents typical powder properties relevant to flow and processing.
| Functional Characteristics | |
|---|---|
| Property | Specification |
| Grade | DuraLac® H |
| Angle of repose (°) | 42 |
| Density bulk (g/l) | 670 |
| Density tapped (g/l) | 880 |
| Hausner ratio | 1.31 |
| Carr’s index (%) | 23.86 |
AI Summary: Presents the controlled air-jet-sieving limits used to assess particle-size distribution.
| Particle Size Distribution | ||
|---|---|---|
| Parameter | Method | Specification |
| Particle size distribution < 45 µm | Ph. Eur. 2.9.38, air-jet sieving | NMT 20% |
| Particle size distribution < 150 µm | Ph. Eur. 2.9.38, air-jet sieving | 40–65% |
| Particle size distribution < 250 µm | Ph. Eur. 2.9.38, air-jet sieving | NLT 80% |
AI Summary: Presents the composition, moisture, purity and elemental limits most relevant to initial material assessment.
| Key Specifications | |
|---|---|
| Parameter | Specification |
| Assay: Lactose calculated on the anhydrous basis | 98.0-102.0% |
| Water determination | NMT 1.0% |
| Loss on drying | NMT 0.5% |
| Residue on ignition | NMT 0.1% |
| Related substances | NMT 0.5% |
| Heavy metals | NMT 5 µg/g |
| Arsenic (As) | NMT 2 µg/g |
AI Summary: Shows the microbiological acceptance limits.
| Microbial Contamination | |
|---|---|
| Parameter | Specification |
| Total aerobic microbial count (TAMC) | NMT 100 cfu/g |
| Total combined yeasts and molds count (TYMC) | NMT 10 cfu/g |
| Escherichia coli | Absence/10 g |
| Salmonella spp. | Absence/100 g |
AI Summary: Shows the material identity, appearance, and solubility.
DuraLac® H
Anhydrous lactose supplied as a white or almost white, crystalline, odourless powder. It consists of beta-lactose or a mixture of beta-lactose and alpha-lactose. It is freely but slowly soluble in water and practically insoluble in ethanol 96%, chloroform, and ether.
AI Summary: Common guidance on storage conditions and proper handling of the material.
What is DuraLac® H?
An anhydrous lactose grade supplied by MEGGLE.
What does DuraLac® H contain?
Beta-lactose or a mixture of beta-lactose and alpha-lactose.
Which pharmacopoeias does it comply with?
USP-NF, Ph. Eur., JP, and ChP requirements for anhydrous lactose.
Is DuraLac® H suitable for vegetarian products?
Yes, it is suitable for a vegetarian diet.
How should it be stored?
In tightly closed, unopened original packaging at room temperature under dry and odour-free conditions.
AI Summary: Summarizes the supply format and conditions required to maintain product quality.
Storage, Packaging and Shelf Life
- Packaging: 25 kg carton box with an aluminium-laminated inliner.
- Store unopened at room temperature.
- Keep under dry and odour-free conditions.
- Avoid significant changes in relative humidity.
- Shelf life: 36 months in the unopened package.
AI Summary: Shows the recommended formulation and processing applications.
Application
- Low- to medium-dose direct-compression formulations
- Dry granulation, including roller compaction and slugging
- Capsule filling
- Sachets